Cleared Traditional

K090907 - PENTA LEAD KITS

K090907 is an FDA 510(k) clearance for PENTA LEAD KITS, manufactured by Advanced Neuromodulation Systems. The device is a Class 2 Neurology device with product code GZB cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K090907 · Advanced Neuromodulation Systems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
62d
Days
Class 2
Risk

K090907 is an FDA 510(k) clearance for the PENTA LEAD KITS, MODELS: 3227-3234. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Advanced Neuromodulation Systems (Plano, US). The FDA issued a Cleared decision on June 2, 2009 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Neuromodulation Systems devices

FDA 510(k) Submission Details - K090907

510(k) Number K090907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2009
Decision Date June 02, 2009
Days to Decision 62 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 148d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZB Device Classification - Class 2, Special Controls

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 99
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K090907.
RAPID PROGRAMMER
K113611 · St Jude Medical · Apr 2012
MULTI-LEAD TRIALING CABLE MODEL 355531
K102523 · Medtronic, Inc. · Oct 2010
SWIFT-LOCK ANCHOR, MODEL 1192
K092371 · Advanced Neuromodulation Systems · Dec 2009
CINCH ANCHOR, MODEL 1194
K081208 · Advanced Neuromodulation Systems · Jul 2008
WIDE SPACED QUATTRODE LEADS
K072462 · Advanced Neuromodulation Systems · Oct 2007
TRIAL CABLE, 3009
K070847 · Advanced Neuromodulation Systems · Apr 2007